O-Arm 1000 Imaging System (2018-09-06)

Starting date:

September 6, 2018

Posting date:

September 28, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-67854

• 
  Reason
• 
  Affected products

Affected products

O-Arm 1000 Imaging System

Reason

Medtronic is voluntarily completing a field action of installing software ("SW") version 3.1.7. The O-arm 1000 application SW 3.1.7 includes fixes to known software anomalies in SW version 3.1.6 and earlier released versions. The anomalies to be fixed range in effects that affect the system; startup, shutdown, system communication, network communication, motion control, image acquisition, image output, dose reporting, and logs generation. In addition to changes in the SW, the IFU was also revised to note the SW version.

Affected products